Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.

Code Information

Item #70-0230; 70-0231; 70-0232; 70-0234; and 70-0235

Document numbers 60-0237 (all) and 60-3003 (all)

Recalling Firm/Manufacturer

Nephros Inc 41 Grand Ave River Edge NJ 07661-1947

For Additional Information Contact

Ms. Eileen Sukumaran201-343-5202

Manufacturer Reasonfor Recall

Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.

FDA DeterminedCause 2

Labeling False and Misleading

Action

Nephros Inc., sent an Urgent Medical Device Recall letter dated October 29, 2013 to all affected customers via UPS 2nd Day Air. The letter identified the affected product, problem and actions to be taken. Customer are asked to provide a customer information list, immediately remove and discard all affected product labeling materials and any independent labeling materials they have created for the affected products. Customers are instructed to complete and sign the attached Response Form to acknowledge receipt, understanding and compliance with the instruction. For questions contact the Nephros representative at 201-343-5202 x 100.
The letter was also posted at : http://www.nephros.com/download/news/DSU_Recall_Letters.pdf

Quantity in Commerce

3,367 untis with affected labeling

Distribution

USA Nationwide Distribution

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.